Saying Sorry May Not Be Good Enough For Novartis

Novartis has issued a formal apology over misconduct relating to valsartan (Diovan) research in Japan, but that apology does not appear likely to satisfy the Japanese Health, Labor and Welfare Ministry, which plans to fully investigate the company's role in the scandal. If necessary, ministry officials are prepared to raid the company's offices in Japan.

A Novartis official apologized to the Japanese public for the apparent manipulation of data. David Epstein, the head of the pharmaceutical division at Novartis, met with the Japanese health minister. "We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry," Epstein was quoted by Reuters after the meeting. He said the company was "willing to work with" Japanese investigators and will "take additional actions and potential sanctions in order to bring the issue to a good conclusion."

Epstein laid the blame for the scandal on a former Novartis employee who participated in the trials and acted "way beyond what we consider appropriate." As previously reported here, that employee, Nobuo Shirahashi, worked on both the Kyoto and Jikei Heart Studies but did not disclose that he was actually an employee of Novartis. In response to the accusations, Shirahashi told an expert panel assembled by the Japanese ministry that he had no involvement in any data manipulation, according to a report in The Mainichi. The expert panel found that Shirahashi was involved not only in the previously reported studies from the Jikei University School of Medicine and the Kyoto Prefectural University of Medicine, but was also involved in valsartan research conducted at Shiga University of Medical Science, Chiba University, and Nagoya University.

Two other once-prominent Japanese cardiologists, Seibu Mochizuki, who was the principal investigator of the Jikei Heart Study, and Hiroaki Matsubara, the principal investigator of the Kyoto Heart Study, also denied any wrongdoing to the expert panel. They placed the blame for any misdonduct on Shirahashi.

The expert panel is not just looking at individual responsibility. According to an AFP news report, the panel has concluded that Novartis "should be held responsible for studies at various universities that used manipulated data on a popular blood pressure drug." The panel is scheduled to complete its preliminary investigation on September 30, after which it will launch a full-scale investigation. According to The Mainichi:

The Pharmaceutical Affairs Act forbids companies from taking out ads in which they intentionally use false or exaggerated expressions to have many people use their drugs and medicines. Violators of the law could face up to two years in prison or a fine of up to 2 million yen. The health ministry could impose administrative punishments such as revoking manufacturing and distribution licenses and impose business-suspension orders on pharmaceutical companies for violating the law.

Novartis issued the following statement in response to reports of the Japanese investigation:

“On September 26, David Epstein, Division Head of Novartis Pharmaceuticals, met with Mr. Norihisa Tamura, the Minister of Health, Labor and Welfare of Japan following an invitation by the Minister. Novartis expressed its regret for the inconvenience caused by the valsartan investigator initiated trails (IITs) in Japan and expressed its continued willingness to address and overcome this issue in Japan.

Novartis is aware of recent media reports concerning the investigation by the MHLW into the Japanese IITs. To date, the MHLW has not published the interim report related to their investigation. Novartis will not speculate on outcomes until we receive official notification from the MHLW.

Novartis takes allegations of conflict of interest and reliability of data very seriously. In April, we launched an investigation using third party experts to investigate these allegations. The investigation has now been completed and confirmed there was an undisclosed COI but did not discover any evidence of willful manipulation or falsification of data in these studies.

Novartis Pharma K.K. (NPKK), Japan has taken preventive and corrective measures to address the causes identified in the third party investigation, including redesigning the standard operating procedures (SOP) for IITs and retraining employees on Conflict of Interest guidelines and process for IITs.

Novartis remains committed to conducting clinical research in Japan and bringing new medicines to patients in Japan, in accordance with applicable laws and regulations while following the highest standards of ethical business conduct in all aspects of our work.”